Last Updated on August 13, 2024 by The Health Master
Form 483
Gland Pharma, a leading global injectable pharmaceutical company, announced today that the United States Food and Drug Administration (USFDA) has completed a routine inspection of its Pashamylaram facility in Hyderabad and issued Form 483.
The unannounced inspection, conducted between July 25 and August 2, 2024, focused on evaluating the facility’s adherence to Good Manufacturing Practices (GMP) standards.
Minor Procedural Observations Issued
At the conclusion of the inspection, the USFDA issued Form 483 with three observations.
However, the company clarified that these observations are of a procedural nature and do not relate to any data integrity issues or repeat findings.
Gland Pharma has committed to submitting a detailed corrective and preventive action (CAPA) plan to the USFDA within the stipulated timeframe.
Gland Pharma: A Global Injectable Leader
Gland Pharma is a prominent player in the global injectable pharmaceuticals market, with a strong presence in over 60 countries, including the United States, Europe, Canada, Australia, and India.
The company boasts a diverse product portfolio encompassing:
- Vials,
- Ampoules,
- Pre-filled syringes,
- Lyophilized vials,
- Dry powders,
- Infusions,
- Oncology, and
- Ophthalmic solutions.
Notably, Gland Pharma was a pioneer in introducing Heparin technology in India.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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